If you’re requesting approval for an existing accessory, the FDA typically grants or denies the request within 85 days. For new accessories, the FDA will make its decision concurrently with the decision on the parent device. Once an accessory is approved, the FDA publishes a final classification order in the Federal Register providing public notice of the decision. That way, stakeholders can see the accessory’s classification type to get an understanding of specific requirements it must meet.
If the FDA doesn’t agree with the recommendation for classification submitted in a request, they will not make the submission and associated decision public. However, the FDA will provide a written response to the submitter, including the basis for denying the request.